Commissioning
Engineering acceptance of equipment and system function.
Validate
Validation
Commissioning, qualification, and validation, nested from engineering acceptance to full GxP. All inside PE ZD’s scope.
2,000 m² cell-therapy pilot plant
Qualification
Engineering and QA acceptance for a GxP laboratory or manufacturing plant.
Validation
Hardware, software, and process parameters together, for full GxP readiness.
HVAC — Leak test, PAO, air balance, recovery.
- CleanroomAir changes, ΔP, particles, light, airflow
- HVACLeak, PAO, balance, recovery
- Process gasGas qualification
- WaterPW / WFI qualification
- SterilizerAutoclave qualification
- Cold chainCold room, warehouse, mapping
- ComputerizedPLC / CSV
測試 is Commissioning. 驗證 is Qualification. 確效 is Validation. The same Taiwan team runs them to international GxP standards.